TEMAZEPAM capsule

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

TEMAZEPAM (UNII: CHB1QD2QSS) (TEMAZEPAM - UNII:CHB1QD2QSS)

متاح من:

Amneal Pharmaceuticals LLC

INN (الاسم الدولي):

TEMAZEPAM

تركيب:

TEMAZEPAM 7.5 mg

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

Temazepam capsules are indicated for the short-term treatment of insomnia (generally 7 to 10 days). For patients with short-term insomnia, instructions in the prescription should indicate that temazepam capsules should be used for short periods of time (7 to 10 days). The clinical trials performed in support of efficacy were 2 weeks in duration with the final formal assessment of sleep latency performed at the end of treatment. Temazepam capsules contain temazepam, a Schedule IV controlled substance. Temazepam is a benzodiazepine and a CNS depressant with a potential for abuse and addiction. Abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. Misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a healthcare provider or for whom it was not prescribed. Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take

ملخص المنتج:

Temazepam capsules, USP 7.5 mg are hard gelatin capsules with white opaque body printed radially “583” with black ink and blue opaque cap printed radially “AMNEAL” with black ink. They are available as follows: Bottles of 30:                            NDC 65162-583-03 Bottles of 100:                          NDC 65162-583-10 Bottles of 500:                          NDC 65162-583-50  Bottles of 1000:                        NDC 65162-583-11  Temazepam capsules, USP 15 mg are hard gelatin capsules with white opaque body printed radially “556” with black ink and blue green opaque cap printed radially “AMNEAL” with black ink. They are available as follows: Bottles of 30:                            NDC 65162-556-03  Bottles of 100:                          NDC 65162-556-10 Bottles of 500:                          NDC 65162-556-50 Bottles of 1000:                        NDC 65162-556-11 Temazepam capsules, USP 22.5 mg are hard gelatin capsules with white opaque body printed radially “584” with black ink and dark pink opaque cap printed radially “AMNEAL” with black ink. They are available as follows: Bottles of 30:                            NDC 65162-584-03 Bottles of 100:                          NDC 65162-584-10 Bottles of 500:                          NDC 65162-584-50 Bottles of 1000:                        NDC 65162-584-11 Temazepam capsules, USP 30 mg are hard gelatin capsules with white opaque body printed radially “557” with black ink and white opaque cap printed radially “AMNEAL” with black ink. They are available as follows: Bottles of 30:                            NDC 65162-557-03 Bottles of 100:                          NDC 65162-557-10 Bottles of 500:                          NDC 65162-557-50  Bottles of 1000:                        NDC 65162-557-11  Dispense in a well-closed, light-resistant container with a child-resistant closure. Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Manufactured by: Amneal Pharmaceuticals of NY LLC Brookhaven, NY 11719 Distributed by: Amneal Pharmaceuticals LLC Glasgow, KY 42141 Rev. 02-2023-05

الوضع إذن:

Abbreviated New Drug Application

نشرة المعلومات

Amneal Pharmaceuticals LLC
----------
MEDICATION GUIDE
Temazepam (tem az’ e pam) Capsules, USP CIV
What is the most important information I should know about temazepam
capsules?
•
Temazepam capsules are a benzodiazepine medicine. Taking
benzodiazepines with opioid medicines,
alcohol, or other central nervous system (CNS) depressants (including
street drugs) can cause severe
drowsiness, breathing problems (respiratory depression), coma and
death. Get emergency help right
away if any of the following happens:
•
shallow or slowed breathing
•
breathing stops (which may lead to the heart stopping)
•
excessive sleepiness (sedation)
Do not drive or operate heavy machinery until you know how taking
temazepam capsules and opioids
affects you.
•
Risk of abuse, misuse, and addiction. There is a risk of abuse,
misuse, and addiction with
benzodiazepines including temazepam capsules which can lead to
overdose and serious side effects
including coma and death.
•
Serious side effects including coma and death have happened in people
who have abused or misused
benzodiazepines, including temazepam capsules. These serious side
effects may also include
delirium, paranoia, suicidal thoughts or actions, seizures, and
difficulty breathing. Call your
healthcare provider or go to the nearest hospital emergency room right
away if you get any of these
serious side effects.
•
You can develop an addiction even if you take temazepam capsules as
prescribed by your healthcare
provider
•
Take temazepam capsules exactly as your healthcare provider
prescribed.
•
Do not share your temazepam capsules with other people.
•
Keep temazepam capsules in a safe place and away from children.
•
Physical dependence and withdrawal reactions. Temazepam capsules can
cause physical dependence
and withdrawal reactions.
•
Do not suddenly stop taking temazepam capsules. Stopping temazepam
capsules suddenly can cause
serious and life-threatening side effects, including, unusual
movements, responses, or expressions,
seizures, sudden and severe

خصائص المنتج

TEMAZEPAM- TEMAZEPAM CAPSULE
AMNEAL PHARMACEUTICALS LLC
----------
TEMAZEPAM CAPSULES, USP
CIV
RX ONLY
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE,
MISUSE, AND ADDICTION; AND DEPENDENCE AND WITHDRAWAL
REACTIONS
CONCOMITANT USE OF BENZODIAZEPINES AND OPIOIDS MAY RESULT IN
PROFOUND SEDATION, RESPIRATORY DEPRESSION, COMA, AND DEATH. RESERVE
CONCOMITANT PRESCRIBING OF THESE DRUGS IN PATIENTS FOR WHOM
ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE. LIMIT DOSAGES AND
DURATIONS TO THE MINIMUM REQUIRED. FOLLOW PATIENTS FOR SIGNS AND
SYMPTOMS OF RESPIRATORY DEPRESSION AND SEDATION (_SEE _WARNINGS
_AND _PRECAUTIONS).
THE USE OF BENZODIAZEPINES, INCLUDING TEMAZEPAM, EXPOSES USERS TO
RISKS OF ABUSE, MISUSE, AND ADDICTION, WHICH CAN LEAD TO OVERDOSE OR
DEATH. ABUSE AND MISUSE OF BENZODIAZEPINES COMMONLY INVOLVE
CONCOMITANT USE OF OTHER MEDICATIONS, ALCOHOL, AND/OR ILLICIT
SUBSTANCES, WHICH IS ASSOCIATED WITH AN INCREASED FREQUENCY OF
SERIOUS ADVERSE OUTCOMES. BEFORE PRESCRIBING TEMAZEPAM AND
THROUGHOUT TREATMENT, ASSESS EACH PATIENT’S RISK FOR ABUSE, MISUSE,
AND ADDICTION (_SEE _WARNINGS).
THE CONTINUED USE OF BENZODIAZEPINES, INCLUDING TEMAZEPAM, MAY LEAD
TO CLINICALLY SIGNIFICANT PHYSICAL DEPENDENCE. THE RISKS OF DEPENDENCE
AND WITHDRAWAL INCREASE WITH LONGER TREATMENT DURATION AND HIGHER
DAILY DOSE. ABRUPT DISCONTINUATION OR RAPID DOSAGE REDUCTION OF
TEMAZEPAM AFTER CONTINUED USE MAY PRECIPITATE ACUTE WITHDRAWAL
REACTIONS, WHICH CAN BE LIFE-THREATENING. TO REDUCE THE RISK OF
WITHDRAWAL REACTIONS, USE A GRADUAL TAPER TO DISCONTINUE TEMAZEPAM
OR REDUCE THE DOSAGE (_SEE _DOSAGE AND ADMINISTRATION_ AND_
WARNINGS).
DESCRIPTION
Temazepam, USP is a benzodiazepine hypnotic agent. The chemical name
is 7-chloro-
1,3-dihydro-3-hydroxy-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one,
and the
structural formula is:
C
H CLN O MW = 300.74
Temazepam, USP is a white, crystalline substance, very slightly
soluble in water and
sparingly soluble in alcohol USP.
Temazepam capsules USP, 7.5 mg, 15 mg, 22.5 mg, and 30 mg, are for
oral
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